NCT02003287已完成不适用
Determining the Efficacy of Using FEES Compared to VFSS to Diagnose Laryngeal Penetration and Aspiration in Infants in the Neonatal Intensive Care Unit (NICU)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- High sensitivity and specificity values for FEES
研究概览
简要总结
The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration when compared with the Videofluoroscopic Swallowing Study (VFSS) in bottle-feeding infants in the NICU. A secondary objective is to determine whether FEES can be used to detect laryngeal penetration and tracheal aspiration in breastfeeding NICU infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 37 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •37 weeks or more postmenstrual age
- •Diagnosis or suspicion of laryngeal penetration and/or tracheal aspiration by neonatal therapist and/or physician
- •Inpatient at Baylor University Medical Center NICU
排除标准
- •Not medically stable enough to undergo both FEES and VFSS as determined by neonatal therapist and/or physician
- •Bilateral complete cleft lip and palate
结局指标
主要结局
High sensitivity and specificity values for FEES
时间窗: one year
次要结局
- Evidence of laryngeal penetration or tracheal aspiration during breastfeeding(at time of assessment)
研究者
研究点 (2)
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